MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC RADIAL JAW 4 2.8MM; FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	M00513330
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Biopsy forceps tip and needle broke off whilst taking a biopsy from the patients stomach.Thorough inspection of the patients stomach and duodenum carried out.Located the spike and removed using a new set of forceps.Reported to the manufacturer via the representative.Fda safety report id #: (b)(4).

• Brand Name: BOSTON SCIENTIFIC RADIAL JAW 4 2.8MM
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10288859
• Report Number: MW5095566
• Device Sequence Number: 2624157
• Product Code: FCL
• UDI-Device Identifier: 08714729745549
• UDI-Public: 01087147297455491723012710251190
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2023
• Device Catalogue Number: M00513330
• Device Lot Number: 25119030
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 73